Senior Quality Engineer, Change Control


Advanced Sterilization Products is recruiting for a Senior Quality Engineer, Change Control to be located in Irvine, CA.

Healthcare-associated infections (HAIs) have a devastating personal and economic impact, claiming the lives of 99,000 people in the U.S. each year at a cost of up to $45 billion. Ensuring that all surgical devices are properly sterilized is one way healthcare workers can help reduce the incidences of HAIs, and Advanced Sterilization Products (ASP) has been partnering with hospitals for decades to safeguard patient health and safety. ASP has a strong track record of designing and delivering innovative infection-prevention solutions, from low-temperature steam sterilization to high-level disinfection, and is a global market leader setting the standard in sterilization.

Johnson & Johnson announced that it has received a binding offer from Fortive Corporation to acquire Advanced Sterilization Products(ASP). If the offer is accepted, the proposed transaction would be expected to close no later than early 2019, subject to customary closing conditions and regulatory approvals. Should you receive and accept an offer for this position, upon completion of the transaction, your employment with ASP will transfer to Fortive according to local law and will be governed by Fortive’s employment processes, programs, policies and benefits plans.


You, the Senior Quality Engineer is responsible for providing engineering support to the Change Process at ASP; Facilitates Change orders through the process by effectively guiding Change Order Owners to complete a thorough change and adequate documentation; Responsible for scheduling and conducting Change Control Board (CCB) meetings to approve changes; Provides technical input to conduct a thorough impact assessment of change and also to ensure the change meets regulatory requirements; Change Control include but are not limited to working under limited supervision; Facilitates Change Orders (CO) through process; Ensures data integrity of each CO to assure clarity and completeness. Verifies change classification; Analyzes and evaluates supporting documentation to ensure that each change is effective; May provide technical direction and consultation to technical support staff or other organizations; Develops metrics to evaluate the effectiveness and efficiency of the Change Order process; Schedules the Change Control Board meetings and prepares the agenda. Chairs CCB meetings and confirm team consensus, resolve outstanding issues; Promotes configuration management principles and train others on its importance; Promotes good documentation practices and proper management of data and records; Designs and recommends improvements to team processes, procedures and tools; Provides support during Internal and External Audits of the Change Control process; Provides task coordination for all Change Control Quality Engineers; Leads process improvement projects to achieve system metrics; Other duties as assigned.



Qualifications
  • A Bachelor of Science and a minimum of 4 years of related experience is required.
  • A degree in a science and/ or a technical field (for example, Mathematics, Statistics, Electrical Engineer, Mechanical Engineering, Computer Engineering, Industrial Engineering, Chemical Engineering, Chemistry, Biology, Public Health etc.) is preferred.
  • Knowledge of PLM (Product LifeCycle Management), document and data control software systems is required.
  • Knowledge of FDA and ISO 13485 requirements are required.
  • Effective interpersonal and communication skills are required.
  • Previous experience with configuration management of product data and process instruction is preferred.
  • Experience in working in change control and/or configuration management systems is required.
  • Experience in working with product development and/or manufacturing is required.
  • Effective team leadership skills are preferred.
  • Experience working with global suppliers and partners is preferred.
  • Knowledge/understanding of the following is required: rules of part number interchangeability; effectivity Statements; configuration Management; business Systems Interrelationships, and multi-site, multi-database BOM structure and interactions; and product processes as they relate to manufacturing sites, system hierarchy and control/traceability requirements.
  • Understanding of manufacturing and engineering disciplines are required.
  • The ability to drive business process improvements and will be highly organized is preferred.
  • A Configuration Management Certification is preferred.
  • This position will be located in Irvine, CA and may require up to 10 - 15% domestic and/or international travel.

Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.



Primary Location
United States-California-Irvine
Organization
Advanced Sterilization Products (ASP)
Job Function
Quality (Eng)
Requisition ID
7140180719